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[00027] "Optional" or "optionally" as used herein means that the subsequently described event or circumstance can or cannot occur, and that the description includes instances where the event or circumstance occurs and instances where it does not

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Core analytical requirements include: Primary structure confirmation using LC-MS/MS to verify intact mass, sequence integrity and detect modifications Impurity profiling (e.g., sequence variants, degradation products) using high-resolution techniques such as UHPLC-HRMS Aggregation and molecular weight analysis using orthogonal methods like SEC-MALS and sedimentation velocity analytical ultracentrifugation (SV-AUC)